Tamper-proof and tamper-resistant containers for housing medication have been designed for various types of medical equipment and applications. Such past medical containers were of all sizes and shapes and were created for patient protection and safety among other reasons. Accordingly, products in the medical field which limit easy intentional or unintentional access to potentially harmful substances are desirable as they help to preserve a variety of healthcare expectations with respect to handling medication safely. In the drug delivery field, such safety considerations have been sometimes referred to as the five rights of medication safety, that is, right patient, right drug, right dose, right route, and right time. Devices which can help maintain control over access to medication once it enters a patient environment are accordingly important tools in attempts to preserve many of these rights.
One specific area in which such secure medication housings have been useful was in the context of infusion pumps, and more particularly, ambulatory infusion pumps. In the past, some ambulatory infusion pumps have used cassette attachments containing bag reservoirs of medication as the source of medication for administration to patients. In general, most of these cassette designs were small enclosures that housed only a limited amount of medication. Often these cassettes were simply one piece devices that were ultrasonically sealed at manufacture. Some of these cassettes provided characteristics of readily portable containers capable of protecting a reservoir of medication, as well as providing an interface which could be quickly recognized by and secured in an operable fashion to an infusion pump.
Despite the advantages of past cassettes, the design of these types of cassettes caused them to be unsuitable to use in various situations. For example, some treatments required larger amounts of medication to be available than could be housed in existing cassettes. In such cases, multiple cassettes were necessary. Further, additional starting and stopping of treatment was required. These limitations were undesirable and inconvenient in many circumstances. Moreover, these designs did not lend themselves easily to a simple enlargement of the cassettes as similarly configured cassettes would require large cumbersome devices.
Further, a frequent issue in past cassette designs was the difficulty pharmacists had removing air bubbles from medication bags fitted within previously sealed cassettes. Specifically, air bubbles were difficult to remove in many past cassette designs because the medication bags were located in ultrasonically sealed cassettes that could not be directly accessed when filled. Accordingly, removing air bubbles once inside the cassette was not easy as the entire cassette and bag would need to be shaken, tapped or jolted.
Therefore, what is needed is an enclosure device which overcomes the deficiencies of the past, and which enables a medication cassette that may be coupled to a peristaltic ambulatory infusion pump and which can house a large amount of medication. Further, although a tamper resistant enclosure is desired when the device is used by patients, it is also desired for the enclosure to allow easy access by a pharmacist for filling with medication and removing air bubbles from the reservoir prior to patient use.